AOAC OMA# 2011.14 (Final Action Review)-OMB

SPIFAN Expert Review Panel Report September 29, 2015 Final Version

IV. REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR FINAL ACTION OFFICIAL METHOD SM STATUS The Expert Review Panel (ERP) reviewed Two (2) methods for Final Action Official Methods SM status. Zero (0) methods were recommended to the Official Methods Board (OMB) for Final Action Official Method SM consideration.

Method Title

Reviewer(s) Sneh Bhandari Brendon Gill/

Vote

Comments

Method

 Copper did not meet SMPR for LOQ  Clarification on LOQ  Need diversity of infant formula  Need justification from ERP on SMPR

OMA# 2011.14 (MTE-01) - 2013 AOAC INTERNATIONAL AOAC Official Method 2011.14 Calcium, Copper, Iron, Magnesium, Manganese, Potassium, Phosphorus, Sodium, and Zinc in Fortified Food Products

Bill Mindak (Moved) Brendon Gill (Second) Motion: withdrawn _________________ Method not recommended Action Official Method SM status with a change in the applicability for infant formula Jon DeVries (Moved) Sarwar Gilani (Second) Yes-2/ No-11/Abstain-2 _________________ Method not recommended for Final Action status *Method retains First Action Official Method SM status for Final Action status *Method retains Final

Minerals & Trace Elements

Harvey Indyk Don Gilliland

 Only one (1) sample was used for D 2  Exclude HPLC  8/16 had performance issues  Next steps o Open call for methods o Discuss with stakeholders

OMA# 2011.11 (VitD-01) - Vitamin D - Determination of Vitamin D2 and D3 in Infant and Adult/Pediatric Nutritionals and Utilizing Ultra High Performance Liquid Chromatography/Tandem Mass Spectrometry (UHPLC- MS/MS)

Sneh Bhandari Brendon Gill/ Harvey Indyk

Vitamin D

IV. REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR REPRODUCIBILITY TESTING The ERP will collectively discuss the methods and select a single method to move forward through the AOAC SPIFAN process for reproducibility testing.

Method Evaluation Forms - Methods processed via the numbering system:

Method Title

Number Voting

Comments

Method

OMA# 2014.04 ( Car n-05) - Single Laboratory Validation of CARN-05: Determination of Free and Total Carnitine and Choline in Infant Formulas and Adult Nutritional Products OMA# 2015.10 ( Car n-07) - Analysis of Free and Total Carnitine and Choline in Infant Formula and Adult Nutritionals OMA# 2015.08 (Chlor-02) - Infant Formula and Adult Nutritionals Chloride by Potentiometry OMA# 2015.07 (Chlor-04) Chlorine in Infant Formula and Adult/Pediatric Nutritional Formula by Potentiometric Titration OMA# 2013.13 (Fol-21) - Single-Laboratory Validation - Free Folates in Infant Formula and Adult/ Pediatric Nutritional Formula by UHPLC-UV

Carnitine/ Choline

1204

~Move to reproducibility testing

1207

 CAIQ & Nestle to work together to get one method

Chloride

~Move to reproducibility testing

1413

1411

No Vote

 Method doesn't do bound folate  Nestle & Silliker to work together and write up a document explaining - should harmonize.  Exact match label compound  define "total"  If you leave in "use internal standard" remove the compound  Defer to March 2016

Folate

Page 4